MAUDE Adverse Event Report: STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number VICMO12.6

Device Problems Failure to Unfold or Unwrap (1669); Appropriate Term/Code Not Available (3191); Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 01/30/2016

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But is not marketed in the u.S.(b)(4).

Event Description

Reporter indicated that the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens in to the patient's left eye (os) on (b)(6) 2016.The reporter indicated that the lens did not unfold completely.The lens was exchanged with the back up lens and the problem was resolved.

Manufacturer Narrative

(b)(4) not applicable, should be under patient code.Conclusion code: per dfu for this lens model, vicmos are contraindicated for patients under the age of 21 years old.Device evaluation: lens was returned in liquid in lens case/vial.Visual inspection found haptic torn/broken/bent/deformed.Claim# (b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5579301
• MDR Text Key: 42743988
• Report Number: 2023826-2016-00472
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: VICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR